| 张伟,马莹.酶促化学发光法测定血清治疗药物监测室间质评分析[J].安徽医药,2026,30(4):692-695. |
| 酶促化学发光法测定血清治疗药物监测室间质评分析 |
| Analysis of external quality assessment results for serum therapeutic drug monitoring using enzyme chemiluminescence method |
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| DOI：10.3969/j.issn.1009-6469.2026.04.011 |
| 中文关键词: 化学发光测定法 质量控制 治疗药物监测 室间质评 液相色谱质谱法 血清药物浓度 |
| 英文关键词: Chemiluminescent measurements Quality control Therapeutic drug monitoring External quality assessment Liq-uid chromatography-mass spectrometry Serum drug concentration |
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| 中文摘要: |
| 目的将酶促化学发光法( CLELA)测定血清类药物浓度的结果，与作为金标准的色谱、质谱方法的检测结果进行比较。方法 2024年 1—12月，使用全自动酶促化学发光免疫分析仪将卡马西平、苯妥英、丙戊酸、地高辛、茶碱试剂盒经校准后，对国家临床检验中心全国血清治疗药物监测 EQA计划提供的 10支样本(编号 202411~202415、202421~202425)进行测定， 2次测定时间覆盖 2024年全年，分析酶促化学发光免疫分析仪检测的数据与国家临床检验中心血清类药物浓度测定上报数据的差异。结果 CLELA检测的室间质评样本与国家临床检验中心公布的液相色谱质谱法数据比值显著高于 80%，且显著低于 120%，其中卡马西平各批号 2种方法比值数据结果统计为( 94.11±5.05)%，地高辛为( 103.35±4.91)%，丙戊酸为( 99.89±3.64)%，苯妥英为( 105.86±3.36)%，茶碱为( 107.59±2.70)%。结论 CLELA检测血清类药物浓度在其便捷、高效、准确方面均有着一定的优势。 |
| 英文摘要: |
| Objective To compare the results obtained from the enzymatic chemiluminescence assay (CLELA) for determining serumdrug concentrations with those from chromatographic and mass spectrometry methods, which are considered as gold standards, by par-ticipating in the external quality assessment activities organized by the National Clinical Laboratory Center.Methods From January toDecember 2024, Using a fully automated enzymatic chemiluminescence immunoassay analyzer, ten samples (Nos. 202411-202415, 202421-202425) provided by the National Center for Clinical Laboratories (NCCL) for the National External Quality Assessment (EQA)Program of Serum Therapeutic Drug Monitoring were measured. The assays were performed using carbamazepine, phenytoin, valproicacid, digoxin, and theophylline reagent kits after calibration. The two measurement time points spanned the entire year of 2024. Thisstudy analyzed the discrepancies between the data detected by the enzymatic chemiluminescence immunoassay analyzer and the datareported to the NCCL for serum drug concentration determination.Results The ratios of the external quality assessment (EQA) sample results detected by the enzyme-enhanced chemiluminescence immunoassay to the reference data from the National Center for ClinicalLaboratories (NCCL) determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) were significantly higher than 80%and significantly lower than 120%. The statistical results of the method comparison ratios for each batch number were as follows: carba-mazepine (94.11±5.05)% , digoxin (103.35±4.91)% , valproic acid (99.89±3.64)% , phenytoin (105.86±3.36)% , and theophylline(107.59±2.70)%.Conclusion The enzymatic chemiluminescence method for detecting serum drug concentrations offers certain advan-tages in terms of convenience, efficiency, and accuracy. |
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